Claims Testing and Clinical Efficacy Studies

A cosmetic claim is a statement of fact, not marketing copy, and the evidence has to exist before the claim is published. Where a claim is precise, quantified or destined for advertising, that evidence is primary clinical data, collected on consenting human subjects under controlled conditions and analysed to a standard a regulator will accept. That is what a clinical efficacy study provides.

Why the claim wording comes first

The framework is Article 20 of Regulation (EC) No 1223/2009, given operational detail by the six Common Criteria of Commission Regulation (EU) No 655/2013, legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making, and by the European Commission Technical Document on Cosmetic Claims. In Great Britain the same Common Criteria apply through the UK Cosmetic Products Enforcement Regulations 2013, with the CAP and BCAP Codes enforced by the Advertising Standards Authority and pre-cleared by Clearcast where the claim is to be televised.

The governing principle is that the evidence must be proportionate to the claim. A claim such as “reduces wrinkle depth by 20% in 28 days” demands instrumental measurement on a powered panel; a softer claim such as “helps smooth the look of fine lines” can often be carried by expert grading or validated self-assessment. This is why a study cannot be scoped from “anti-ageing and brightening” alone. We need the exact words, the market, and where the claim will appear, because broadcast carries the highest evidential bar.

One point we flag early: anti-ageing and brightening claims must stay within cosmetic function, the improvement of appearance. Wording that implies treating a medical condition, depigmenting as a medicinal action, or permanently altering skin physiology can push a product across the borderline into a medicinal classification, a different and far more onerous regime. We keep claims firmly on the cosmetic side of that line.

Measuring anti-ageing claims

Anti-ageing is an umbrella, not a claim. It resolves into distinct, separately measurable strands, each with its own endpoints and instruments.

Wrinkles and fine lines (depth, volume, count) are measured by three-dimensional in vivo skin topography (fringe projection, such as PRIMOS or DermaTOP), by silicone negative replicas read by optical profilometry to ISO 4287, by high-resolution cross-polarised photography with image analysis, and by expert clinical grading against validated photonumeric scales. A percentage-reduction claim needs the instrumental route; an “appearance of” claim can rest on grading.

Firmness, elasticity and sagging are measured by Cutometer suction-deformation, reporting the standard R-parameters (R0, R2, R5, R7), supporting “firmer”, “more elastic” and “lifted” claims.

Texture, pores and density are measured by the topography and profilometry methods above, by polarised imaging for pores, and by high-frequency (20 MHz) ultrasound for dermal density, supporting “denser” and “plumper-looking” claims.

Hydration and barrier are measured by corneometer (capacitance) and tewameter (transepidermal water loss), underpinning “moisturising” and “plumping” claims.

Measuring brightening claims

Dark spots and uneven pigmentation, framed within cosmetic scope as reducing the appearance of dark spots and evening skin tone, are measured by reflectance spectrophotometry (Mexameter, reporting the Melanin Index), by tristimulus colorimetry (CIE L*a*b*), by cross-polarised and ultraviolet photography for spot count and intensity, and by expert grading.

Radiance, luminosity and glow are measured by colorimetry, where L* captures luminosity and the Individual Typology Angle captures overall tone, by glossymeter for surface radiance, and by expert assessment. A quantified “brighter skin” claim typically rests on a statistically significant increase in L* or ITA.

Across all of these, a validated consumer self-assessment questionnaire supports “X% of users agreed” claims, which sit alongside, and are distinct from, the instrumental claims.

How the study is run

We conduct paired-comparison clinical efficacy studies under the supervision of a qualified Clinical Pharmacologist, following Declaration of Helsinki principles and Good Clinical Practice, with informed consent, dermatological supervision and ISO 9001 quality management. Subjects are measured at baseline and at defined timepoints. Trained, blinded assessors evaluate against quantitative endpoints, and the data are analysed using paired t-tests, Cohen’s d effect size and 95% confidence intervals, with gender-stratified analysis where panel size permits. You receive a full study report suitable for inclusion in your Product Information File and for advertising substantiation.

Following the rejection of an earlier industry-prepared study, a UK personal-care brand owned by a major multinational commissioned us to produce the efficacy study for their televised campaign. Clearcast’s review concluded that the study presentation was of a high standard in relevance, clarity and thoroughness, and accepted it in full.

Panels, pricing and timelines

Our standard panels run at 15, 30 and 60 subjects, with the 60-subject panel the benchmark for broadcast substantiation. Fees start from £5,000 plus VAT for 15 subjects, £8,500 for 30 and £14,500 for 60. The price does not fall in proportion to panel size, because the cost sits in the fixed study infrastructure, the protocol, ethics, calibration, blinded assessor time, statistics and the supervised report, rather than the per-subject rate. Smaller and bespoke panels are scoped from the same £5,000 floor, though a small panel may not deliver the statistical power to show a significant effect on subtler endpoints, so for advertising, and broadcast in particular, a larger panel is the sounder investment.

On timing, plan for three to five months end to end. The total is driven by the in-use observation period, typically 8 to 12 weeks for wrinkle, pigmentation and brightening endpoints, with protocol design, ethics and recruitment before it and analysis and reporting after. Clinical studies are quoted and invoiced in full before commencement.

What we need to quote precisely

To turn this into a firm scope, price and timeline, send the exact wording of each claim, the market (GB, EU or both), where each claim will appear, the product and how it is used, and whether you want measurement against baseline only or against a comparator. As a first step we carry out a brief review of which claims are reasonably substantiable, then design the study around those, which keeps you from paying to test a claim that was never going to clear.

This service sits above documentary claims review, which assesses claims against the Common Criteria at the desk. For the principles behind both, see our guide to substantiating anti-ageing and brightening claims.